Professional Summary

• Regulatory Affairs/Quality Professional and Medical and Technical Writer/Editor with extensive experience in Medical Device, Manufacturing, and Managed Health Care. Background includes interfacing with Engineering, Regulatory, Quality, and other Subject Matter Experts in order to advise on regulatory and quality strategy and write and edit regulatory and technical documentation including Technical Files, Design Dossiers, 510 k and PMA submissions, Clinical Evaluation Reports, protocols, validations, policies and procedures, clinical summaries, SOP's, labeling, and training materials. Expertise extends to executive summaries, marketing copy, proposals, speeches, presentations, and press releases. Developing productive working relationships with technical and health care professionals, notified bodies, regulatory agencies, and government representatives is a noted strength.
• Professional and Consulting Experience 1998-2014

Medical/Technical Writer

Confidential

Prepare technical files, design dossiers, 510 k , and PMA submissions. Instrumental in obtaining and maintaining market authorizations for medical devices domestically and internationally. Research and write clinical evaluation reports and clinical experience summaries. Prepare presentations and informational notes for notified bodies and government representatives. Advise on regulatory strategy, risk management activities, QMS compliance. Class I, II, and III devices.

Recent clients include:

• ConMed/Linvatec
• Boston Scientific
• MedComp

Confidential

• Consulted on process and researched and prepared regulatory documentation for a major international manufacturer of Class II and III medical devices. ISO 13485 environment.
• Researched, managed, and compiled Technical File updates for products implantable stents, vascular access products which were successful in satisfying audit by a Notified Body in order to maintain compliance to MDD 93/42/EEC 2007/47/EC for CE marking.
• Worked with Engineering and Quality Assurance Subject Matter Experts to define Risk Management strategy and determine Risk Management content for Technical Files and Design Dossiers.
• Consulted with Regulatory Affairs team to define processes for updating documentation in response to internal CAPA initiative. Developed Technical File template which was adopted as the new standard by the Regulatory Affairs Department
• Performed literature searches, acquired and reviewed post-market surveillance data from Subject Matter Experts, and edited Clinical Evaluation Reports required for inclusion in Technical Files according to revised MDD 2007/47/EC .
• Worked with Engineering and Quality Assurance Subject Matter Experts to define Risk Management strategy and determine Risk Management content for Technical Files and Design Dossiers.
• Prepared Design Dossier Supplements to report significant changes in product or process to European Community third party representative Notified Body .
• Researched and wrote responses to questions from Notified Body which supported subsequent approval of process changes.
• Consulted with Subject Matter Experts in Engineering, Quality, Biocompatibility, Labeling, and Design groups as well as third party manufacturers in order to acquire and confirm regulatory information.
• Provided training, mentoring, and expertise to new personnel joining the Regulatory Affairs team.

Confidential

Consultant Project Manager/Technical Writer/Editor

• Consulted with product design staff to re-engineer processes and revise/edit Divisional Operating Procedure DOP documentation relating to medical device product manufacturing endoscopic instrumentation .
• Integrated regulatory issues including cGMP's, QSR's, CE, OSHA requirements, etc.
• Developed presentations and obtained buy-in from management board to facilitate and implement process revisions, with the goal of improving Portfolio Management, increasing research and development efforts, and achieving product marketing goals.
• Developed new process training materials presented training on new and revised procedures to engineering and regulatory staff as well as to the management board.

Confidential

Consultant Medical Writer/Project Manager

• Facilitated annual review of Policy and Procedure documentation for various departments of a major managed health care organization by providing technical editing, writing, and documentation management expertise. Familiar with URAC and HIPAA requirements.
• Drafted/edited Medical and Network Management policy and procedure documentation to maintain compliance with URAC regulatory standards and renew URAC certification.
• Developed copy for an Intranet web site to be used for training company employees on regulatory issues and procedures.
• Facilitated Draft Committee meetings, prepared documentation for Approval Committee review
• Assisted in regulatory accreditation efforts for Network Management Department
• Provided expertise and advice on content and development of proposals, presentations, and other company documentation. Analyzed and re-engineered documentation processes.

Confidential

Consultant Communications Analyst/Technical Writer

• Analyzed requirements, wrote and edited technical documentation for IT Infrastructure department - client/server technologies. Wrote project communications and conducted oral presentations to business groups and management. Facilitated project meetings and assisted project lead.
• Provided technical writing and communications analysis for Windows 2000 Standard Client Project, an enterprise-wide client upgrade.
• Worked with software engineers to meet project deliverables, prepare/edit build specifications, QA documents, installation procedures, functional specifications, etc.
• Developed proposals, presentations, project documentation for presentation to management.
• Web site design and development. Researched emerging technologies, prepared gap analyses and flowcharts, wrote SOP's.

Confidential

Consultant Regulatory Affairs/Technical Writer

• Researched and wrote regulatory compliance documentation for international manufacturer of medical devices. Devices included angiographic, thermodilution, multiple lumen, electrophysiology, and cholangiography catheters.
• Prepared product design dossiers and technical files required to receive CE mark authorization for Class II and III medical device distribution in the European Union.
• Ensured compliance with ISO standards and Medical Device Directive. Worked with engineers and materials specialist to compile product risk analyses and biocompatibility data.
• Wrote clinical data summaries for FDA and European Medical Competent Authority documentation submissions. Used Internet research tools including MedLine.
• Investigated and responded to requests for clarification from European Notified Body, leading directly to European marketing approval for company products.
• Generated Standard Operating Procedure SOP documents. Created manufacturing process flowcharts using ABC Flowcharter and Visio. Assisted in design of Documentum database.
• Accepted total responsibility for a comprehensive documentation submission for a medical device/pharmaceutical combination.
• Reviewed product promotional/marketing brochures for content and style.
• Acted as liaison to Medical Device authorities and company personnel in Germany, United Kingdom, and South Africa.

Confidential

Consultant Public Relations/Marketing Communications

• Provided Customer Outreach Department of regional natural gas provider with marketing letters, brochures, customer communications, and press releases. Worked with customers and community agencies to identify Outreach Program requirements.
• Created marketing copy including promotional customer outreach brochures and letters. Worked with in-house print shop to coordinate design and layout of brochures and other promotional materials. Provided copy for company newsletter and web site.
• Provided a liaison with the Salvation Army, American Red Cross and Public Utility Commission.
• Worked with utility customers to identify requirements for Community Outreach programs.
• With a team of consultants, designed and implemented a customized MS Access database application, including on-line data entry forms and reports.

Confidential

News Broadcaster/Writer

• Employing resources including newswire services, interviews, and local publications, researched/wrote/ edited news copy. Anchored hourly live news broadcasts.
• Wrote copy and provided taped voice productions for radio advertisements.